Estimating Human Immunodeficiency Virus (HIV) Prevention Effects in Low-incidence Settings.

ABSTRACT:

Background

Randomized controlled trials (RCTs) for determining efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) infection have not been conducted among US women because their lower HIV incidence requires impractically large studies. Results from higher-incidence settings, like Sub-Saharan Africa, may not apply to US women owing to differences in age, sexual behavior, coinfections, and adherence.

Methods

We propose a novel strategy for evaluating PrEP efficacy in the United States using data from both settings to obtain four parameters: (1) intention-to-treat (ITT) and (2) per-protocol effects in the higher-incidence setting, (3) per-protocol effect generalized to the lower-incidence setting, and (4) back-calculated ITT effect using

SUBMITTER: Rudolph JE 

PROVIDER: S-EPMC6456405 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature